NCT06498999

Brief Summary

The goal of this clinical trial is to develop a comprehensive Training Program intervention for social media addiction called the 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS) and to learn if the 4-STEP-TPS will address and help manage the problems related to social media addiction. Other key objectives include the management of dysfunctional patterns, the promotion of positive patterns and healthy lifestyle, and the promotion of daily life activities and productivity. Young Adult participants will take the 4-week 4-STEP-TPS Program with 1 weekly session in either individual or group settings or be placed on a waitlist control.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 1, 2024

Last Update Submit

July 8, 2024

Conditions

Keywords

Training Program4-STEP-Training Program for Social Media AddictionSocial Media AddictionSocial NetworkingFlourishingDysfunctional PatternsFatigue Assessment Scale (FAS)Intervention

Outcome Measures

Primary Outcomes (7)

  • Social Networking Addiction Scale (SNAS)

    The Social Networking Addiction Scale (SNAS) was developed to measure addiction of all forms of social networking across six-dimensions salience (items 1-4), mood modification (items 5-7), tolerance (items 8-10), withdrawal (items 11-14), conflict (item 15-17), and relapse (items 18-21) (Shahnawaz \& Rehman, 2020). The SNAS is a self-reported scale which entails 21-items scale rated on 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The score can range from 21 to 147. Any score above a total score of 84 signifies addiction. The scale has demonstrated good test-retest reliability of 0.88 and good validity as reported by Shahnawaz and Rehman (2020).

    At screening, after 4 weeks, and reassessment up to 6 months

  • Secure Flourish Index (SFI)

    The Secure Flourish Index (SFI) was developed to measure long-term flourishing across 6 domains happiness and life satisfaction (items 1-2), physical and mental health (items 3-4), meaning and purpose (items 5-6), character and virtue (items 7-8), close social relationships (items 9-10), and financial and material stability (items 11-12) (Weziak-Bialowolska et al., 2017). It is a self-report scale with 2 items for each of the 6 domains, totaling to 12 items rated on a scale of 0-10. Total scores range from 0 to 120 with higher scores indicating greater flourishing. It has an internal consistency of 0.85 and good construct validity (Weziak-Bialowolska et al., 2017).

    At screening, after 4 weeks, and reassessment up to 6 months

  • Fear of Missing Out Scale (FoMOs)

    The Fear of Missing out Scale (FoMOs) was developed to measure FoMO (Przybylski et al., 2013). It is a self-report questionnaire of 10-items rated on a 5-point Likert scale ranging from 1 (not at all true of me) to 5 (extremely true of me). The total scores of the scale range between 10 and 50, where higher scores indicate a higher level of fear of missing out. The scale has been shown to exhibit strong internal consistency of 0.87 to 0.90 and good validity (Przybylski et al., 2013).

    At screening, after 4 weeks, and reassessment up to 6 months

  • Pubbing Scale (PS)

    The Phubbing Scale was developed to measure the phubbing behaviors (Karadağ et al., 2015). The scale contains 10 items, rated from 1 (never) to 5 (always) in a 5-point Likert scale, the following 2 factors were found: (i) Factor 1 (1-5 items; α = .87) and (ii) Factor 2 (6-10 items; α = .85). The content of these factors can be summarized as follows: (i) Communication disturbance: Higher scores indicate that participants often disturb their existing communications by dealing with their mobile phones in a face-to-face communication environment. (ii) Phone obsession: Higher scores indicate that participants constantly need their mobile phone in environments lacking face-to-face communication.

    At screening, after 4 weeks, and reassessment up to 6 months

  • Fatigue Assessment Scale (FAS)

    The Fatigue Assessment Scale (FAS) was developed to evaluate the physical and mental symptoms of fatigue (Michielsen et al., 2003). It is a self-report measure with 10 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The scale has 2 subscales, with mental fatigue measured by the sum of items 3, 6, 7, 8, and 9 and physical fatigue measured by the sum of items 1, 2, 4, 5 and 10. Items 4 and 10 are reverse-scored. The total scores range from 10, indicating the lowest level of fatigue, to 50, indicating the highest level of fatigue. The scale has an internal consistency of 0.90 and good validity (Michielsen et al., 2003).

    At screening, after 4 weeks, and reassessment up to 6 months

  • Insomnia Severity Index (ISI)

    The Insomnia Severity Index (ISI) was developed as a screening measure for insomnia as well as an outcome measure in treatment research (Bastien et al., 2001). It is a self-report measure with 7 items rated on a 5-point Likert scale ranging from 0 to 4. The total scores range from 0 to 28, with higher scores indicating more acute insomnia symptoms. Although not validated, the developers suggest cutoff scores to be used for interpretation, with total scores of 0-7 indicating "no clinically significant insomnia," scores between 8-14 indicating "subthreshold insomnia," scores between 15-21 indicating "clinical insomnia (moderate severity)," and scores in the range 22-28 indicating "clinical insomnia (severe)." The scale has an internal consistency of 0.74 (Bastien et al., 2001).

    At screening, after 4 weeks, and reassessment up to 6 months

  • Depression, Anxiety and Stress Scales (DASS)

    The DASS-21 is the shortened version of the DASS-42 was designed to measure the symptoms of depression, anxiety, and stress (Lovibond \& Lovibond, 1995). It is a self-report measure with 21 items rated on a 4-point Likert scale ranging from 0 to 3. Each of the three DASS-21 scales depression (items 3, 5, 10, 13, 16, 17, 21), anxiety (items 2, 4, 7, 9, 15, 19, 20), and stress (items 1, 6, 8, 11, 12, 14, 18) contains 7 items. The scale has good internal consistency and construct validity in both clinical and non-clinical samples (Antony et al., 1998). Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. After obtaining the final score for each depression, anxiety, and stress, the final score is compared to the recommended cut-off scores for severity levels (normal, moderate, severe).

    At screening, after 4 weeks, and reassessment up to 6 months

Study Arms (3)

Experimental Group: Individual Setting

EXPERIMENTAL

4-STEP-Training Program in 1-1 Setting

Behavioral: 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)

Experimental Group: Group Setting

EXPERIMENTAL

4-STEP-Training Program in Group Setting

Behavioral: 4-STEP-Training Program for Social Media Addiction (4-STEP-TPS)

Control Group

NO INTERVENTION

No Intervention

Interventions

4 Modules with 1 Module being delivered in 1 weekly session of approximately 90 minutes. The details of each module/step is described as follows: Step 1 (Module 1): S = Screening, Assessment and Psychoeducation: Involves screening and assessment of the problem, interpretation of the results, feedback and psychoeducation, identifying and breaking the resistance, motivation, and conceptualization. Step 2 (Module 2): T = Treatment Conceptualization and Planning: Involves pattern identification, distortion identification, as well as pattern and distortions modifications. Step 3 (Module 3): E = Effective Management Strategies: Involves management strategies to treat the earlier identified patterns as well as the implementation and confirmation of activities via a Pattern Schedule Chart. Step 4 (Module 4): P = Prevention (Lapse-Relapse): Involves self-reflection and support building, monitoring and dependency check and slip plans and support additions

Experimental Group: Group SettingExperimental Group: Individual Setting

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range: 18-30 years
  • No physical, psychiatric, or psychological conditions
  • Minimum score of 84 on the Social Networking Addiction Scale (SNAS)
  • Minimum score of 60 on the Secure Flourish Index (SFI)

You may not qualify if:

  • Age below 18 or above 30 years
  • Presence of any physical, psychiatric, or psychological conditions
  • Score below 84 on the Social Networking Addiction Scale (SNAS)
  • Score below 60 on the Secure Flourish Index (SFI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government College University Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Qasir Abbas, PhD

    Assistant Professor - Clinical Psychology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qasir Abbas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized control trial design will be used in this study. It will be a three-arm study with the following groups: (1) an experimental group receiving the intervention in a group setting, (2) an experimental group receiving the intervention in an individual setting, and (3) a waitlist control group. In this research, a parallel group design will be used, with treatment given to all participants in a parallel manner. The allocation ratio and framework will be equivalence, meaning that each of the three groups will have an equal number of participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Clinical Psychology

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 12, 2024

Study Start

May 15, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations